- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328091
Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen) (ProGen)
January 17, 2024 updated by: Huma Rana, MD, Dana-Farber Cancer Institute
This randomized controlled trial aims to evaluate the impact of pre-test video education and post-test genetic counseling as compared to in-person pre-test genetic counseling in males with advanced prostate cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomized to either pre-test video education and post-test genetic counseling or in-person pre-test genetic counseling.
Outcomes evaluated are: prevalence of germline mutations, uptake of genetic testing, satisfaction with testing, knowledge of multi-gene panels, distress, result disclosure to relatives, and the impact on personal or family medical care.
Through this study, the investigators will learn about the inherited causes of prostate cancer, and how and when genetic testing should be offered to this population.
Study Type
Interventional
Enrollment (Actual)
662
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
-
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Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
- Localized prostate cancer with Gleason score ≥8
- Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months
- Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart
- Prostate cancer diagnosed at age ≤ 55 years
- Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer.
- Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)
Exclusion Criteria:
- Previous cancer genetic testing or counseling, or prior germline multigene panel testing. Previous tumor sequencing is acceptable if no genetic counseling took place.
- Localized prostate cancer previously treated and in remission for > 2 years unless family history potentially indicates a germline mutation.
- Active hematologic malignancy (e.g. CLL)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Traditional pre-test genetic counseling
|
Participant meets with a genetic counselor at the Center for Cancer Genetics and Prevention and traditional pre-test cancer genetic counseling is provided
|
Experimental: Pre-test video education
|
The video is designed to mirror the educational components of a traditional genetic counseling visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of germline mutations in males with prostate cancer
Time Frame: 2 years
|
The proportion of participants who test positive for pathogenic or likely pathogenic variants
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic testing uptake
Time Frame: 2 years
|
The proportion of participants who consent to genetic testing in the pre-test video education arm
|
2 years
|
Secondary or other primary (non-prostate) malignancies
Time Frame: 2 years
|
Assessed by chart review.
Participants with positive genetic test results will fill out the "Positive Test Results" Survey to report any additional cancer diagnoses.
|
2 years
|
Genetic testing satisfaction score
Time Frame: at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure
|
A validated survey of participants' satisfaction with the genetic counseling and testing process will be used.
For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit.
The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly".
At the time of 1 month post-result disclosure, an additional set of 5 questions will be added.
Four of these five questions will be evaluated using the previously described parameters.
The remaining question will be answered by the response options: "yes", "no", or "I did not get the packet".
Survey responses will be re-coded on a numerical scale consistent with the standard Likert scale.
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at time of post-counseling/video pre-result disclosure and at 1 month post-result disclosure
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Multidimensional Impact of Cancer Risk Assessment score and subscales
Time Frame: 1 and 4 months post-result disclosure
|
MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer.
Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale.
Section 2 contains two items for participants who have children.
Section 3 contains 2 items for participants who have/have had cancer.
Responses are indicated on a 4 point scale for experiences in the past week.
A higher score in the sub-scales or total scale indicated greater distress.
The positive sub-scale is reverse scored to reflect this.
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1 and 4 months post-result disclosure
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Knowledge of multigene panel testing score
Time Frame: 4 months post-result disclosure
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A 24 item investigator-developed knowledge scale applicable to this population was developed through an expert panel and in-depth patient cognitive interviews to determine if participants are able to recall key core components about multi-gene panel testing.
Each item provides three choice answers: "agree", "disagree", or "I don't know".
Knowledge will be scored on the number of "correct" responses where higher correct responses represents more knowledge of multigene panel testing.
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4 months post-result disclosure
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Family communication for those who tested positive for a genetic mutation
Time Frame: 1 and 4 months post-result disclosure
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For those participants who have tested positive for a mutation, 5 items will be asked pertaining to disclosure of genetic testing results to relatives that are derived from previous literature.
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1 and 4 months post-result disclosure
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Intent to disclose genetic test results
Time Frame: pre-result disclosure
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Three items will assess participants' intentions to disclose genetic testing results.
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pre-result disclosure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Huma Q Rana, MD, Dana-Farber Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2017
Primary Completion (Actual)
February 13, 2020
Study Completion (Actual)
February 13, 2020
Study Registration Dates
First Submitted
October 25, 2017
First Submitted That Met QC Criteria
October 27, 2017
First Posted (Actual)
November 1, 2017
Study Record Updates
Last Update Posted (Estimated)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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